The Daily Biotech Pulse: COVID Disappointments For Altimmune And Angion, Brickell Jumps On Hyperhidrosis Study Updates, 2 IPOs

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 29)

• 10x Genomics, Inc. TXG
• Ambrx Biopharma Inc. AMAM
• Celldex Therapeutics, Inc. CLDX
• Cerevel Therapeutics Holdings, Inc. CERE ( announced positive Phase 1b data for Schizophrenia treatment)
• Graphite Bio, Inc. GRPH (IPOed Friday)
• Harvard Bioscience, Inc. HBIO
• Intellia Therapeutics, Inc. NTLA (follow-through buying triggered after the first-ever human trial results for gene-editing therapy)
• Intuitive Surgical, Inc. ISRG
• Lantheus Holdings, Inc. LNTH
• MiMedx Group, Inc. MDXG
• Moderna, Inc. MRNA ( reacted to positive COVID-19 vaccine data as well as authorization for emergency use of the vaccine in India)
• Recursion Pharmaceuticals, Inc. RXRX
• ResMed Inc. RMD
• Sesen Bio, Inc. SESN
• ShockWave Medical, Inc. SWAV
• Verve Therapeutics, Inc. VERV
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 29)

• Achilles Therapeutics plc ACHL
• Bolt Biotherapeutics, Inc. BOLT
• Elevation Oncology, Inc. ELEV (IPOed Friday)
• Celyad Oncology SA CYAD
• Exelixis, Inc. EXEL
• Freeline Therapeutics Holdings plc FRLN
• Gemini Therapeutics, Inc. GMTX
• Global Blood Therapeutics, Inc. GBT
• IMV Inc. IMV
• Madrigal Pharmaceuticals, Inc. MDGL
• Medicenna Therapeutics Corp. MDNA
• Mersana Therapeutics, Inc. MRSN
• Neoleukin Therapeutics, Inc. NLTX
• ORIC Pharmaceuticals, Inc. ORIC
• Sensei Biotherapeutics, Inc. SNSE (announced prioritization of its pipeline programs)
• Tempest Therapeutics, Inc. TPST
• Terns Pharmaceuticals, Inc. TERN
• VectivBio Holding AG VECT
• Vivos Therapeutics, Inc. VVOS

Stocks In Focus

Altimmune Winds Up COVID-19 Program

Altimmune, Inc. ALT provided an update on the Phase 1 AdCOVID clinical trial evaluating the safety and immunogenicity of the intranasally administered vaccine candidate, showing lower than expected immune responses for each of the immune parameters tested.

Moving forward, Altimmune will focus its resources on the development of ALT-801 and HepTcell, its novel peptide-based therapeutics for obesity and liver diseases, the company said.

Additionally, the company said it's unable to enroll subjects in the final cohort of the Phase 1/2 trial of T-COVID, which is being evaluated for the prevention of clinical worsening in patients with early COVID-19. As a result of these enrollment challenges, the company said it has decided to terminate further enrollment and evaluate options for future T-COVID development following an assessment of the available data and discussions with its partners, the U.S. Army Medical Research & Development Command and the Medical Technology Enterprise Consortium.

The stock was plunging 33.96% to $10.50 in premarket trading.

Angion's ANG-3777 Flunks a Mid-stage COVID-19 Study

Angion Biomedica Corp. ANGN said its exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome did not meet the primary or secondary efficacy endpoints.

The company said it has decided not to continue the development of this COVID-19 program. Based on the promising activity of ANG-3777 in multiple animal models of lung injury, the company intends to continue to evaluate the clinical development of ANG-3777 for acute lung injury populations.

In premarket trading, Angio shares were losing 10.80% to $12.89.

Brickell Biotech Announces Commencement of Second Pivotal Phase 3 Hyperhidrosis Study

Brickell Biotech, Inc. BBI announced that the final patient has completed the Phase 3 pivotal Cardigan I study, and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis.

The stock was jumping 20.43% to $1.12 in premarket trading.

Dynavax Strikes a Deal to Supply Advanced Adjuvant for Use In Clover's COVID-19 Vaccine

Clover and Dynavax Corporation DVAX announced the execution of a commercial supply agreement of Dynavax's CpG 1018 advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019.

The commercial supply agreement extends to the end of 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between CEPI and Dynavax.

Separately, Clover announced an advanced purchase agreement with Gavi, the Vaccine Alliance, for supplying up to 414 million doses of SCB-2019 through 2022 for the COVAX Facility.

Dynavax shares were up 1.01% at $9.97 in premarket trading.

ObsEva Announces Positive Data From a Pilot Study of Yselty In Severe Adenomyosis

ObsEva SA OBSV announced presentation at the European Society of Human Reproduction and Embryology annual meeting, clinical data from a pilot study on Yselty (linzagolix) for the treatment of severe adenomyosis, showing a full-suppression dose of Yselty reduces uterine and adenomyosis lesion size, as well as abnormal uterine bleeding and pelvic pain.

The company also presented data from ongoing clinical programs, namely Yselty for the treatment of uterine fibroids and nolasiban for uterine contractility of IVF patients prior to embryo transfer.

The stock was up 3.32% at $3.11 in premarket trading.

Guardant Health Discloses Institutional Ownership

Guardant Health, Inc. GH revealed in a filing SVF Bluebird has a 0.6% stake in the company.

Fulcrum Gains On Insider Buying

Fulcrum Therapeutics, Inc. FULC disclosed through a series of filing insiders, including James Geraghty, a director of the board, Peter Thomas, VP Finance & Accounting, and Christopher Morabito, chief medical officer, have bought shares in the company.

In premarket trading, the stock was at $9.85, a 3.58% gain.

Avita Medical Added to the Russell 3K Index

AVITA Medical, Inc. RCEL, a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced that as part of the annual reconstitution of the Russell stock indexes, it has been added to the Russell 3000 Index effective June 28.

Offerings

Cerevel said it has commenced an underwritten public offering of 14 million shares of its common stock. All shares to be sold in the proposed offering will be sold by Cerevel.

The stock was down 8.39% at $27.20 in premarket trading.

Kiromic BioPharma, Inc. KRBP said it has priced its underwritten public offering of 8 million shares of its common stock at a public offering price of $5 per share, for gross proceeds of $40 million. All of the shares of common stock are being offered by the company.

In premarket trading, the stock was slumping 24.70% to $5.

Panbela Therapeutics, Inc. PBLA said it has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3.33 million shares at a price to the public of $3 per share. The closing of the public offering is expected to occur on or about July 2, subject to satisfaction of customary closing conditions. The gross proceeds of the offering are expected to be approximately $10 million.

The stock was plunging 24.61% to $2.88 in premarket trading.

Addex Therapeutics Ltd ADXN said it has entered into a sales agreement with Cantor Fitzgerald acting as sales agent, to offer ADSs, each representing six shares with no nominal value through an at-the-market offering program. The ADSs to be sold under the prospectus supplement shall not exceed $16.0 million, it added

On The Radar

IPO

Minnesota-based medical device maker CVRx announced priced its upsized initial public offering of 7 million shares at $18, for raising gross proceeds of $126 million. The company had earlier estimated a price range of $15-$17. The shares of the commercial-stage medical device company focused on developing and commercializing minimally invasive neuromodulation solutions for patients with cardiovascular diseases will begin trading on the Nasdaq under the ticker symbol CVRX.

Boston, Massachusetts-based Aerovate Therapeutics, Inc. priced its upsized IPO of 8.682 million shares at $14, the midpoint of the estimated price range of $13-$15. The shares of the clinical-stage biopharma focusing on treatments for cardiopulmonary diseases will begin trading on the Nasdaq under the ticker symbol AVTE. The offering is expected to raise gross proceeds of $121.5 million.