The Daily Biotech Pulse: Acorda Spikes On Distribution Deal, Alzamend Soars On Data, Pfizer-BioNTech To Supply More Vaccine Doses, 3 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 July 22)

• Bio-Techne Corporation TECH
• BioNTech SE BNTX (announced a collaboration with Biovac to manufacture COVID-19 shots in South Africa)
• Bristol-Myers Squibb Company BMY
• Cassava Sciences, Inc. SAVA
• Century Therapeutics, Inc. IPSC
• Cortexyme, Inc. CRTX (announced positive data for pipeline asset in periodontal disease)
• Eli Lilly and Company LLY
• Erasca, Inc. ERAS (IPOed July 16)
• Horizon Therapeutics Public Limited Company HZNP
• Legend Biotech Corporation LEGN
• NeuroMetrix, Inc. NURO (reacted to its second-quarter results)
• Novo Nordisk A/S NVO
• PLx Pharma Inc. PLXP
• ResMed Inc. RMD
• Sight Sciences, Inc. SGHT (IPOed July 15)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 22)

• 23andMe Holding Co. ME
• 4D pharma plc LBPS
• Akoya Biosciences, Inc. AKYA
• Ardelyx, Inc. ARDX
• Ascendis Pharma A/S ASND
• Biodesix, Inc. BDSX
• Biomea Fusion, Inc. BMEA
• BioXcel Therapeutics, Inc. BTAI
• Coherus BioSciences, Inc. CHRS
• CytomX Therapeutics, Inc. CTMX
• Elevation Oncology, Inc. ELEV
• Esperion Therapeutics, Inc. ESPR
• Freeline Therapeutics Holdings plc FRLN
• Global Blood Therapeutics, Inc. GBT
• HCW Biologics Inc. HCWB (IPOed Tuesday)
• HOOKIPA Pharma Inc. HOOK
• Lumos Pharma, Inc. LUMO
• Medicenna Therapeutics Corp. MDNA
• OptiNose, Inc. OPTN
• Relmada Therapeutics, Inc. RLMD
• Scopus BioPharma Inc. SCPS
• Travere Therapeutics, Inc. TVTX
• TScan Therapeutics, Inc. TCRX (IPOed Friday)
• Vivos Therapeutics, Inc. VVOS
• Vor Biopharma Inc. VOR

Stocks In Focus

Accorda Strikes Distribution Agreement For Parkinson's Disease Drug In Spain

Acorda Therapeutics, Inc. ACOR entered into distribution and supply agreements with Esteve Pharmaceuticals S.A to commercialize Inbrija 33 mg in Spain. Inbrija is indicated in the EU for the intermittent treatment of episodic motor fluctuations, ie OFF episodes, in adult patients with Parkinson's disease treated with a levodopa/dopa-decarboxylase inhibitor.

Under the terms of the supply agreement, Acorda will receive a significant double-digit percent of the selling price of Inbrija in Spain in exchange for supply of the product. Esteve will have exclusive distribution rights in the territory and Acorda will supply the product to Esteve.

Esteve expects to launch Inbrija in Spain in the fourth quarter of 2022.

In premarket trading, the stock was soaring 54.33% to $5.88.

Adverum To Stall Study of Gene Therapy In Diabetic Macular Edema Due to Dose-limiting Toxicity

Adverum Biotechnologies, Inc. ADVM provided an update on the ADVM-022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema and the OPTIC clinical trial in patients with wet age-related macular degeneration. The data from the studies show marked differences in the safety profile between the two patient populations and between the low (versus high doses.

Adverum said it no longer plans future development for DME after a dose-limiting toxicity not seen before in ocular gene therapy or anti-VEGF treatment has been observed at the high dose. The company, however, plans to evaluate ADVM-022, a single intravitreal injection gene therapy, at low doses and with alternative prophylactic regimens in a future Phase 2 clinical trial in wet AMD.

The stock was slipping 20.92% to $2.42 in premarket trading.

Castle Biosciences Announces Positive Study Results For 2 Skin Cancer Gene Expression Profile Tests

Castle Biosciences, Inc. CSTL announced data presentations on two of its skin cancer gene expression profile tests at the Society of Dermatology Physician Assistants Annual Summer Dermatology Conference 2021.

Results from the study of the DecisionDx-Melanoma reinforced its clinical utility of diagnosed with cutaneous melanoma. This study of the company's DecisionDx-SCC demonstrated that the intended use population aligns with the cases that were submitted for clinical testing and that the results can be applied as an adjunct to enhance SCC risk stratification and contribute to risk-appropriate surveillance and treatment decisions.

NGM Biopharma Completes Enrollment Into Phase 2 Study of NGM621 In Geographic Atrophy

NGM Biopharmaceuticals, Inc. NGM said it has completed enrollment in the Phase 2 CATALINA study, which is evaluating the safety and efficacy of intravitreal injections of NGM621 in patients with geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is characterized by progressive retinal cell loss that results in irreversible loss of vision, and there are no approved treatments for geographic atrophy.

The stock was up 4.72% at $22.20 in premarket trading.

Alzamend Announces Positive Toxicology Results From Animal Testing of Alzheimer's Drug Candidate

Alzamend Neuro, Inc. ALZN said it has received positive toxicology results for AL002 in a good laboratory practices toxicology study using a transgenic mouse model of Alzheimer's disease. The study was conducted by Charles River Laboratories.

Al002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's.

In premarket trading, the stock was skyrocketing 72.47% at $9.90.

Related Link: Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates

Pfizer-BioNTech To Supply 200M More Doses of COVID-19 Vaccine to U.S.

Pfizer, Inc. PFE and BioNTech SE BNTX announced that the U.S. government has purchased an additional 200 million doses of their vaccine. These doses are expected to be delivered from October 2021 through April 2022.

This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

Cyclerion Gains On Announcement Regarding Presentation at Alzheimer's Conference

Cyclerion Therapeutics, Inc. CYCN said it will present clinical trial design for a Phase 2a study of its lead development candidate, CY6463, in participants with Alzheimer's disease with vascular pathology at the upcoming Alzheimer's Association International Conference 2021.

The company also said a researcher at the Boston University School of Medicine and Center for Translational and Cognitive Neuroscience will present results from the Cyclerion sponsored study on peak alpha frequency and N200 latency as predictors of neuropsychological performance in a memory disorders clinic.
The stock was adding 9.17% to $3.73 in premarket trading.

NRx Pharma Finds Follow-through Buying On Update On COVID-19 Treatment

NRx Pharmaceuticals, Inc. NRXP is seen extending its Thursday's gains built on the back of its announcement concerning a new formulation of its COVID-19 treatment candidate and manufacturing scale up plan.

The stock was moving up 38.42% at $22.77 in premarket trading.

Ocular Therapeutix Pre-announces Above-consensus Q2 Revenues

Ocular Therapeutix, Inc. OCUL reported preliminary second quarter 2021 total net product revenue of approximately $11.7 million, up 600% year-over-year and 60% higher than in the previous quarter.

Analysts, on average, estimated revenues of $11.6 million for the quarter.

The stock was rising 8% to $13.09 in premarket trading.

Offerings

AzurRx, Inc. AZRX said due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 9.09 million shares of its common stock at 55 cents per share. The closing of the offering is expected to occur on or about July 27, subject to satisfaction of customary closing conditions.

The stock was sliding 23.11% to 54.45 in premarket trading.

IPOs

Sophia Genetics SA SOPH, a AI-driven healthcare data analytics company based out of Switzerland, priced its initial public offering of 13 million shares at $18 apiece, for raising gross proceeds of $234 million. The shares of the company will begin trading on the Nasdaq under the ticker symbol "SOPH."

Caribou Biomedical, Inc. CRBU, a clinical-stage CRISPR genome-editing biopharmaceutical company, priced its upsized IPO of 19 million shares of common stock at $16 per share. All of the shares of common stock are being offered by Caribou. The gross proceeds of the offering are expected to be $304 million.

The shares are expected to begin trading on the Nasdaq Global Select Market on July 23, 2021, under the ticker symbol "CRBU."

Cytek Biosciences, Inc. CTKB, a cell analysis solutions company, priced its IPO of an aggregate of 16.75 million shares of its common stock at $17 per share. The gross proceeds to Cytek from the offering are expected to be $200 million.

Cytek is offering 11.77 million shares of common stock and the selling stockholders named in the prospectus are offering 2.8 shares of common stock. Cytek will not receive any proceeds from the sale of shares by the selling stockholders. The shares are expected to begin trading on the Nasdaq under the symbol "CTKB."