Qtrypta (zolmitriptan-coated microneedle patch) / Gylden Pharma - LARVOL DELTA

No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program (FierceBiotech) - "...With the FDA again knocking back its transdermal migraine patch, the biotech has suspended its M207 program and made more layoffs to preserve its dwindling cash reserves....However, the FDA has looked unfavorably on filings, issuing a complete response letter and then refusing to review a resubmission. Zosano recently revealed the toll of the latest setback, disclosing the decision to suspend the M207 program despite the FDA granting it another year to resubmit its new drug application."

Discontinued • CNS Disorders • Migraine • Pain

Zosano Pharma Corporation Receives a Response Letter from the U.S. Food and Drug Administration with Regard to the Company’s January 18, 2022 Resubmission of the 505(b)(2) New Drug Application for M207 (Market Screener) - "On February 17, 2022, Zosano Pharma Corporation received a response letter from the U.S. Food and Drug Administration with regard to the...January 18, 2022 resubmission of the 505(b)(2) New Drug Application for M207 (zolmitriptan microneedle system)....The response letter stated that the FDA did not consider the resubmitted M207 NDA to be a complete response to the deficiencies identified in the...October 19, 2020 Complete Response Letter, and that the FDA will not begin substantive review of the application until a complete response is received."

FDA event • NDA • CNS Disorders • Migraine • Pain

Zosano Pharma Announces Pricing of $15.4 Million Public Offering of Common Stock and Warrants (Yahoo News) - "Zosano Pharma Corporation...announced underwritten public offering of 51,250,000 units, each consisting of one share of common stock and one warrant to purchase one share of common stock, at a public offering price of $0.30 per unit....Zosano intends to use the net proceeds from this offering for pre-commercialization activities and for general working capital and corporate purposes."

Commercial • CNS Disorders • Migraine • Pain

Zosano Pharma Reports Third Quarter 2021 Financial Results (Yahoo News) - "Zosano Pharma Corporation...today announced financial results for the third quarter ended September 30, 2021, as well as business highlights....Research and development expenses for the third quarter of 2021 were $6.0 million, compared with $5.8 million for the same quarter in 2020. The increase was primarily due to the conduct of a pharmacokinetic study to support the resubmission of the NDA for M207, partially offset by lower employee and consulting costs."

Commercial • CNS Disorders • Migraine • Pain

Zosano Pharma Granted Type C Meeting with FDA Regarding NDA Resubmission for M207 Following Preliminary Top-Line Pharmacokinetic Study Results (GlobeNewswire) - "Zosano Pharma...announced the company has been granted a Type C written response only meeting with the U.S. Food and Drug Administration ('FDA') regarding the resubmission of the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application ('NDA') following receipt of preliminary top-line results from the pharmacokinetic ('PK') study....We look forward to providing an update on our resubmission plans after we receive written feedback from the FDA, which is expected to occur by mid-December....Unless and until the company resubmits an NDA and potentially receives FDA approval, the company is unable to estimate a timeframe for product launch or revenues for 2022..."

FDA event • CNS Disorders • Migraine • Pain

Zosano Pharma Announces Issuance of U.S. Patent for Method of Rapidly Achieving Therapeutic Levels with M207 for the Acute Treatment of Migraine (GlobeNewswire) - "Zosano Pharma...announced that it has been granted an additional patent covering method of use of M207 with the issuance of U.S. Patent No. 11,058,630 titled Method of Rapidly Achieving Therapeutic Concentrations of Triptans for the Treatment of Migraines....'As we continue to execute on completing the pharmacokinetic study for the potential resubmission of our NDA for M207, we are very pleased to strengthen our patent portfolio for our innovative product candidate,'...This latest patent adds to Zosano’s M207 patent portfolio, which now includes two U.S. patents with claims covering composition of matter and method of use for M207 with expirations in 2037."

Patent • CNS Disorders • Migraine • Pain

Zosano Pharma Announces Publication of Clinical Data Regarding the Long-term use of Qtrypta for the Treatment of Acute Migraine in The Journal of Headache and Pain (GlobeNewswire) - P2/3, N=365; Zotrip (NCT02745392); Sponsor: Zosano Pharma Corporation; "Zosano Pharma...today announced that an article titled, 'Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine' was published in The Journal of Headache and Pain...The tolerability and efficacy results in this long-term study were consistent with the results observed in the Phase 2/3 ZOTRIP study...The primary outcome measure was the percentage of participants experiencing treatment emergent adverse events over 12 months. Secondary outcomes included the percentage of migraine attacks for which pain freedom and most bothersome symptom freedom were achieved at two hours post-dose, and the percentage for which pain relief was achieved at two hours post-dose."

P2/3 data • CNS Disorders • Migraine • Pain

Zosano Pharma Confirms Plan to Move Forward with Pharmacokinetic Study Following Protocol Review by FDA (GlobeNewswire) - "Zosano Pharma Corporation...today announced that the company has received feedback from the U.S. Food and Drug Administration ('FDA') Division of Neurology II (the 'Division') on the protocol for the pharmacokinetic ('PK') study required to support the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application ('NDA')...The company expects the study to begin in June and to be completed with data available in the third quarter of 2021. Subject to positive data, Zosano expects to resubmit its NDA for Qtrypta™ by the end of 2021."

FDA event • New trial • PK/PD data • CNS Disorders • Migraine • Pain

[VIRTUAL] Onset of Action of a Zolmitriptan Microneedle System (M207, Qtrypta™) for Migraine: Comparison with Recent Early Time to Onset Recommendations, Pain Relief Results and Placebo Response (AAN 2021) - "M207 met the TG criteria for “early time-to-onset” in the ZOTRIP trial. PF at 30 minutes was always associated with PF at 2 hours in the M207 group; PR at 30 minutes was associated with 2 hour PF in the majority in M207 mg group, but not the placebo group."

Clinical • CNS Disorders • Migraine • Pain

Zosano Pharma Reports Fourth Quarter and Fiscal Year 2020 Financial Results (GlobeNewswire) - "Research and development expenses for the full year 2020 were $21.6 million, compared with $25.4 million in 2019. The decrease of $3.8 million was primarily due to a decrease in pre-clinical and clinical trial costs, related to the completion of the Qtrypta™ long-term safety study, partially offset by an increase in costs associated with the scale up and technology transfer to our commercial manufacturing organizations."

Commercial • CNS Disorders • Migraine • Pain

Zosano Pharma Confirms NDA Resubmission Strategy Following Type A Meeting Minutes from FDA (GlobeNewswire) - "...the company maintains its plans to conduct an additional pharmacokinetic ('PK') study for inclusion in an NDA resubmission package. In a post-meeting comment, the FDA recommended a skin assessment on patients in the planned PK study to generate additional safety information...The company’s plans for resubmitting the NDA are based on the discussions between the company and the FDA and may be subject to change upon receipt of the FDA’s comments to the proposed study protocol."

FDA event • CNS Disorders • Migraine • Pain

Zosano Pharma Requests Type A Meeting with the FDA to Review Resubmission Plans for Qtrypta New Drug Application (GlobeNewswire) - "Zosano Pharma...announced that on December 30, 2020 the company requested a Type A meeting with the U.S. Food and Drug Administration (FDA). The purpose of the Type A meeting is to receive FDA input on the requirements for the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on October 20, 2020."

FDA event • CNS Disorders • Migraine • Pain

Zosano Pharma Presents Early-Onset of Action Data for Qtrypta in Acute Treatment of Migraines (GlobeNewswire) - P2/3, N=365; Zotrip (NCT02745392); Sponsor: Leading BioSciences, Inc; "In a post-hoc retrospective analyses of data from the previously published ZOTRIP trial involving 365 subjects who received Qtrypta 3.8 mg or placebo, of 82 Qtrypta-treated subjects, 38 reported pain relief at 30 minutes, and 28 of the 38 subjects (74%) were pain free at two hours. All 6 subjects treated with Qtrypta who reported pain freedom at 30 minutes were pain-free at two hours. This compares to nine of 26 subjects (35%) in the placebo group (n=77) who reported pain relief at 30 minutes that were pain free at 2 hours, and 1 of 2 subjects that were pain free at 30 minutes being pain free at 2 hours."

Retrospective data • CNS Disorders • Migraine • Pain

Zosano Pharma Announces NDA Resubmission Plans Following Type A Meeting with FDA (GlobeNewswire) - "Zosano Pharma...announced that the company completed its Type A meeting with the U.S. Food and Drug Administration ('FDA') Division of Neurology II (the 'Division') regarding the requirements for resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system)...The company’s plans for resubmitting the NDA are based on the discussions between the company and the Division during the Type A meeting and may be subject to change upon receipt of the FDA’s official meeting minutes from the Type A meeting."

FDA event • CNS Disorders • Migraine • Pain

"The #FDA rejected Zosano's application to repurpose the triptan zolmitriptan in a new delivery system as Qtrypta. https://t.co/rXKzz2lgbZ" (@endpts)

FDA declines to approve Zosano's drug for relieving migraine headaches (Financial Post) - "The U.S. health regulator has declined to approve Zosano Pharma Corp’s experimental treatment to relieve pain after the onset of migraine headaches, citing issues with its delivery during clinical trials, the company said on Wednesday. Shares of the company slumped about 27% to 45 cents before the bell."

FDA event • Stock price • CNS Disorders • Migraine • Pain

"$ZSAN Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta™ https://t.co/6JKY6opxJE" (@stock_titan)

Clinical • FDA event

Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta (GlobeNewswire) - "Zosano Pharma Corporation...announced today that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies....CRL noted differences in zolmitriptan exposures...that made interpretation of some safety data unclear....The FDA recommended that the company conduct a repeat bioequivalence study between three of the lots used during development....Additional product quality validation data, which were planned to be submitted following approval...were required to be submitted with the application....Zosano will request a Type A meeting with the FDA to discuss strategies to discuss strategies to address the FDA’s comments."

FDA event • CNS Disorders • Migraine • Pain

Zosano plunges after FDA discipline review letter for Qtrypta; approval not expected by October 20 (SeekingAlpha) - "Zosano Pharma...plummets 52% after-hours in reaction to receiving a discipline review letter (DRL) from the FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA)....Approval of Qtrypta by the PDUFA goal date of October 20 is not expected given the letter."

FDA event • Stock price • CNS Disorders • Migraine • Pain

Zosano Pharma Receives Preliminary FDA Communication on Qtrypta NDA (GlobeNewswire) - "Zosano Pharma Corporation...today announced that it has received a discipline review letter (DRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA)....Although a DRL reflects preliminary comments that are subject to change, and does not reflect the FDA’s final decision on the NDA, approval of Qtrypta by the Prescription Drug User Fee Act goal date of October 20, 2020 is not expected given the letter."

FDA event • CNS Disorders • Migraine • Pain

Zosano Pharma Announces Partnership Agreement with EVERSANA to Support the Launch and Commercialization of Qtrypta (GlobeNewswire) - "Zosano Pharma Corporation...today announced it has partnered with EVERSANA...to commercialize and distribute Qtrypta™ in the United States....Under the terms of the agreement, the parties will cooperate to conduct activities over the term of the agreement pursuant to an anticipated $250 million commercialization budget for Qtrypta....The term of the agreement is five years following the date of FDA approval."

Licensing / partnership • CNS Disorders • Migraine • Pain

Development of a novel zolmitriptan intracutaneous microneedle system (Qtrypta™) for the acute treatment of migraine. (PubMed, Pain Manag) - "Treatment-emergent adverse events were mild and transient and most commonly concerned the application site. In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat."

Journal • CNS Disorders • Migraine • Pain

Zosano Pharma Reports Second Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "'We are now focused on executing on pre-commercial activities in preparation for Qtrypta’s possible approval later this year and potential subsequent launch in 2021'....Completed a blinded market research study conducted with high-volume physicians and payors...79% of the physicians strongly agree there remains an unmet need in the treatment of migraine in the acute setting, even in patients that respond to preventive therapy; 70% of the physicians would offer their patients a non-oral triptan that has fast and complete pain relief that is sustained and well-tolerated."

Clinical • Launch • CNS Disorders • Migraine • Pain

Zosano Pharma to showcase new post-hoc analyses of Qtrypta’s (M207) clinical trial data comparing key efficacy results from the pivotal study and the open-label long term safety study on the 2020 American Headache Society’s Virtual Annual Scientific Meeting Platform (GlobeNewswire) - "Zosano Pharma Corporation...today announced that new post-hoc efficacy analyses of Qtrypta....Six different measurements of pain reduction from the exploratory efficacy results in the long-term safety study ('LTSS') were examined and compared to the positive clinical results observed in the Phase 2/3 Zotrip study....Similar to the pivotal study, the most common adverse events observed in the LTSS were redness and swelling at the application site, of which more than 95% were classified as mild."

Retrospective data • CNS Disorders • Migraine • Pain

Zosano Pharma enrolls first subject in migraine treatment trial (Reuters) - "Reiterate that we expect to report pivotal efficacy data in q1 2017."

Anticipated P2/3 data • Migraine