FDA Accepts Novan NDA for Molluscum Contagiosum with PDUFA Goal Date of January 5, 2024

 – FDA completes filing review of application with no filing issues identified –

– New Chemical Entity (“NCE”) has potential to be the first FDA-approved prescription product for molluscum in the U.S. –

– Novan’s commercial team and sales force ready to prepare for launch of berdazimer gel, 10.3%, if approved –

Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that the U.S. Food and Drug Administration (“FDA”) accepted for filing Novan’s New Drug Application (“NDA”) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum (“molluscum”). The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.

https://finance.yahoo.com/news/fda-accepts-novan-nda-berdazimer-130000318.html

F-star cleared for planned acquisition

 Parties expect the merger to be completed promptly following the successful completion of the ongoing Tender Offer

 F-star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies to transform the lives of patients with cancer, today announced that the Committee on Foreign Investment in the United States (“CFIUS”) has cleared the previously announced all-cash acquisition of the Company by invoX Pharma Limited (“invoX”).

The CFIUS clearance satisfies the Foreign Investment Condition of the ongoing tender offer (the “Offer”), and is the final required regulatory approval needed to complete the proposed merger. As described below, the parties expect to complete the merger promptly following the successful completion of the ongoing tender offer.

Specifically, the Offer is scheduled to expire on March 8, 2023 at 5 p.m., Eastern Time. Subject to the tendering of shares of F-star common stock representing greater than 50% of the issued and outstanding shares and the satisfaction of customary conditions, the parties expect to complete the merger promptly following this tender expiry. Previously, shares of common stock representing nearly 70% of the issued and outstanding shares had been validly tendered as of the prior expiration dates (before such dates were extended).

Stockholders who need assistance with tendering their shares of common stock of F-star, may contact the Information Agent, Innisfree M&A Incorporated, at the following contact information:

Stockholders May Call Toll-Free:
1 (888) 750-5830 (from the U.S. or Canada)
From outside the U.S. and Canada, please call:
+1 (412) 232-3651
Banks and Brokers May Call Collect:
(212) 750-5833
Email (for material requests only):
info@innisfreema.com

https://finance.yahoo.com/news/f-star-therapeutics-announces-cfius-140000480.html

FDA clears Abbott's blood test for concussions

 The U.S. Food and Drug Administration has cleared Abbott Laboratories' blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday.

The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI.

TBIs are caused by blow or whiplash to the head and can pose risk of short- and long-term effects that can include impairment of memory and movement.

Abbott already has a plasma test for TBI and was cleared by the FDA in 2021.

The new test measures two indicators in the blood that, in elevated concentrations, are tightly correlated to brain injury, the company said

https://finance.yahoo.com/news/1-u-fda-clears-abbotts-143056075.html

Dyadic: Update on Phase 1 Trial for COVID-19 Recombinant Protein RBD Booster

 

• Dosing of all patients was completed at the end of February 

• No Serious Adverse Events (SAE’s) have been reported 

• Phase 1 clinical initial safety and antibody response update expected in Q2, 2023 
  

Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable and accessible biopharmaceutical products for human and animal health, today provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate.

https://finance.yahoo.com/news/dyadic-provides-phase-1-clinical-133000683.html

Zynex to Postpone Fourth Quarter and Full Year 2022 Financial Results Release

  Zynex, Inc. (Nasdaq: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that the company will postpone the release of its fourth quarter and full year financial results and conference call initially scheduled for Monday, March 6, 2023 at 4:15 p.m. ET.

The company will announce its fourth quarter and full year 2022 financial results and conference call schedule in a future press release to allow additional time to complete its year-end closing procedures.

https://finance.yahoo.com/news/zynex-inc-postpone-fourth-quarter-210100946.html

Allakos started at Overweight by Piper

 Target $22

https://finviz.com/quote.ashx?t=ALLK&ty=c&ta=1&p=d

Raymond James cuts Gossamer As Merck's Sotatercept Might Overshadow Seralutinib's Success

 

• Raymond James has downgraded Gossamer Bio Inc (NASDAQ: GOSS) to Market Perform from Outperform following the publication of sotatercept's Phase 3 data in NEJM.

• The analyst has already thought that seralutinib would exhibit weaker efficacy than Merck & Co Inc's (NYSE: MRK) sotatercept in comparable populations.

• Using Hodges-Lehman location shift (HLLS) statistic for 6MWD, Merck reported a difference of 40.8m in Phase 3 compared to LSMD of 24.9m in Phase 2, which makes the development path for seralutinib even more difficult.

• Sotatercept reduced the risk of clinical worsening or death by 84%, supporting the adoption as the new standard of care on top of existing therapies.

• Raymond James writes that Gossamer may need to run another Phase 2 as an add-on to sotatercept or a Phase 3 in FC III patients only.

• Although Gossamer has additional development plans for seralutinib in pulmonary hypertension (PH) due to interstitial lung disease (PH-ILD), a confirmed plan is required.

• The analyst also writes that while PAH program discontinuation would still be a negative catalyst, the market may view the event positively. Gossamer's CNS penetrant BTKi GB5121 currently offers an upside.

https://finance.yahoo.com/news/analyst-downgrades-gossamer-bio-mercks-203751684.html