Daily Biotech Pulse: VistaGen's Anxiety Study Fails, Silverback To Merge With Firm Developing EpiPen Alternative, Setback For Liminal's Lead Asset

Zinger Key Points
  • VistaGen Says PALISADE-1 results are not consistent with prior positive results from Phase 2 trials in social anxiety disorder.
  • Silverback Therapeutics and ARS Pharma merged entity is well-funded with at least three years of operating runway expected.
Daily Biotech Pulse: VistaGen's Anxiety Study Fails, Silverback To Merge With Firm Developing EpiPen Alternative, Setback For Liminal's Lead Asset

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

VistaGen Says Data From Late-Stage Anxiety Study Not Consistent With Prior Positive Phase 2 Study

VistaGen Therapeutics Inc VTGN has announced topline results from its PALISADE-1 Phase 3 trial of PH94B for the acute treatment of social anxiety disorder. 

PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale compared to placebo. 

The tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported trials. 

Shares are slipping 69.2% at 33 cents during the premarket session.

Once Cancer Company Silverback Merges With Small Biotech Working On Allergy Treatment

ARS Pharmaceuticals Inc will merge with Silverback Therapeutics Inc SBTX in an all-stock transaction, with a new entity operating under the ARS Pharmaceuticals moniker and trade on NASDAQ under the SPRY symbol.

The combined company will focus on neffy, ARS's investigational epinephrine nasal spray for Type I allergic reactions, including anaphylaxis. 

The combined entity is expected to have approximately $265 million in cash, cash equivalents, and marketable securities at closing. 

Shares are down 10.4% at $3.94 during the premarket session.

Liminal BioSciences Pulls Plug On Its Lead Development Program

Liminal BioSciences Inc LMNL will discontinue the development of fezagepras based on results from the Phase 1a single ascending dose trial, which indicated that fezagepras was significantly inferior compared to Sodium Phenylbutyrate as a nitrogen scavenger. 

The recommendation to stop the development program for fezagepras was not based on safety concerns.

Also Read: 'Big Short' Investor Michael Burry Says Nancy Pelosi's Chip Stock Buy Should Be Illegal 

Bavarian Nordic's Monkeypox Vaccine Gets Thumbs Up From EU Regulator

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a "positive opinion" recommending Bavarian Nordic A/S's BNVRY smallpox vaccine, Imvanex, be authorized to include protection against monkeypox on its label.

The vaccine is approved for use against monkeypox in the U.S. and Canada, where it is marketed as Jynneos and Imvamune, respectively. It is only authorized for use against smallpox in Europe.

Bavarian Nordic said the regulator asked it to submit more data to expand its market authorization in light of the growing monkeypox outbreak.

Vertex Advances VX-548 in Acute and Neuropathic Pain

Vertex Pharmaceuticals Incorporated VRTX plans to advance the selective NaV1.8 inhibitor VX-548 into Phase 3 trials in the fourth quarter of 2022. 

Vertex also intends to initiate a Phase 2 dose-ranging study of VX-548 in neuropathic pain by the end of this year. 

In addition, the FDA has granted VX-548 Breakthrough Therapy Designation for the treatment of moderate-to-severe acute pain.

Insider Trading

Sekar Kathiresan, the CEO of Verve Therapeutics Inc VERV, disclosed in a filing that he sold 50,000 shares of company stock at $29.90 per share on July 19 for $1,495,000.

Shares are down 2.41% at $32.02 during premarket trading.

Offerings

Addex Therapeutics Ltd ADXN agreed to sell 3.33 million shares in 550,000 ADSs at a gross purchase price of $1.70 per ADS, equivalent to CHF 0.27 per share, for gross proceeds of $4.2 million.

On The Radar

Stock Split

Cellectar Biosciences Inc CLRB: Implementing a reverse stock split based on one share for every ten shares.

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