The Daily Biotech Pulse: Clinical Setback For Adverum, Galera Posts Data Readout, Moderna To Invest In Vaccine Manufacturing, Decision Day For Ardelyx

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 April 28)

• Axonics, Inc. AXNX
• Boston Scientific Corporation BSX (reacted to first-quarter results)
• Celcuity Inc. CELC
• Celldex Therapeutics, Inc. (NASDAQ: CLDX)
• Galectin Therapeutics Inc. GALT
• Horizon Therapeutics Public Limited Company HZNP
• Insulet Corporation PODD
• Integra LifeSciences Holdings Corporation IART (announced first-quarter results)
• Lantheus Holdings, Inc. LNTH
• MacroGenics, Inc. MGNX
• NuVasive, Inc. (NASDAQ: NUVA)
• PRA Health Sciences, Inc. PRAH
• ShockWave Medical, Inc. SWAV
• Verastem, Inc. VSTM

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 28)

• Akoya Biosciences, Inc. AKYA
• Decibel Therapeutics, Inc. DBTX
• IRadimed Corporation IRMD
• Lucira Health, Inc. LHDX
• Mesoblast Limited MESO
• Protara Therapeutics, Inc. TARA
• PTC Therapeutics, Inc. PTCT

Stocks In Focus

Adverum Shares Sink On Serious Adverse Event 

Adverum Biotechnologies, Inc. ADVM announced a suspected unexpected serious adverse reaction of hypotony, which is clinically relevant decrease in ocular pressure, in its INFINITY clinical trial evaluating ADVM-022 gene therapy for the treatment of diabetic macular edema.

This event occurred 30 weeks after randomization in one patient treated with a single intravitreal injection of the high dose of ADVM-022 who has developed hypotony, with panuveitis and loss of vision in the treated eye.

Adverum said it has decided to immediately unmask the INFINITY Phase 2 study to better understand this event and to help identify and manage any similar potential risk to other patients in this study. Additionally, the company is conducting a thorough review of data from the ADVM-022 program and plans to report its findings as the analysis progresses.

The stock was down 52.17% to $4.86 in after-hours trading.

Galera Reports Positive Updated Results For Phase 1/2 Pancreatic Cancer Study

Galera Therapeutics, Inc. GRTX announced updated results from its Phase 1/2 pilot trial of GC4419, versus placebo, in patients with locally advanced pancreatic cancer who are undergoing stereotactic body radiation therapy.

The updated results, as of the data analysis, include a minimum follow up of six months on all 42 patients and were consistent with the positive results reported with a minimum follow up of three months, the company said.

Galera said it plans to report final results from the trial after a minimum of one year of follow up, expected during the second half of 2021.

In after-hours trading, the stock was up 30.11% at $8.60.

Akebia Announces Publication Of Positive Phase 3 Study Results For Lead Drug to Treat Anemia In CKD Patients

Akebia Therapeutics, Inc. AKBA announced publication in the New England Journal of Medicine results of the global Phase 3 clinical program of its lead candidate vadadustat for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and adult patients not on dialysis in two separate manuscripts.

Among patients with anemia and CKD who were undergoing dialysis, vadadustat was non-inferior to Amgen, Inc.'s AMGN Aranesp with respect to cardiovascular safety and maintenance of hemoglobin concentrations, while in patients not undergoing dialysis, vadadustat met the prespecified noninferiority criterion for hematologic efficacy but not the prespecified noninferiority criterion for cardiovascular safety.

Akebia shares were up 7.5% to $3.44 in after-hours trading.

Biogen's Multiple Sclerosis Drug Fails To Win Label Expansion 

Biogen, Inc. BIIB said it has received a complete response letter from the FDA for its supplemental biologic license application for a new subcutaneous route of administration of Tysabri to treat relapsing multiple sclerosis. Biogen said is evaluating the CRL and will determine next steps in the U.S.

The stock lost 1.35% to $264 in after-hours trading.

Cara Announces Mixed Results In Atopic Dermatitis Study

Cara Therapeutics, Inc. CARA announced mixed topline results from its KARE Phase 2 dose-ranging clinical trial of oral Korsuva for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis patients.

The company said the study did not meet the primary endpoint of worst-itch NRS change from baseline at week 12 or secondary endpoint of 4-point responder analysis in the intent-to-treat patient population. However, the study achieved primary endpoint of worst-itch NRS change and secondary endpoint of 4-point responder analysis in pre-specified analyses of mild-to-moderate AD patients, comprising 64% of ITT population.

The stock was down 18.57% to $4.79 in premarket trading Thursday.

Related Link: The Week Ahead In Biotech (April 25-May 1): FDA Decisions For Sol-Gel, Protalix Bio, Ardelyx

Flexion To Present Positive Phase 1 Data For Gene Therapy Candidate In Osteoarthritis

Flexion Therapeutics, Inc. FLXN said it will present at the 2021 American Society of Gene & Cell Therapy annual meeting, preliminary data from a Phase 1 single ascending dose trial of FX201, showing the low dose of FX201, an intra-articular gene therapy candidate for osteoarthritis, was generally well-tolerated.

The company also said two of five patients treated with FX201 in the low-dose, single ascending dose cohort reported substantial improvement in pain out to week 24. There was no evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient.

The stock was up 5.01% to $8.60 in after-hours trading.

Lucira Health Announces Increase In COVID-19 Test Kit Production Capacity With Opening of Partner Jabil's New Facility

Lucira Health, Inc. (NASDAQ: LHDX announced the opening of a new production center in the Dominican Republic by its manufacturing partner Jabil Inc. (NYSE: JBL).

The new facility will increase production of the LUCIRA CHECK IT COVID-19 test kit during the second quarter of 2021. Jabil also manufactures Lucira's unique COVID-19 test in Auburn Hills, Michigan.

Lucira shares were up 1.6% to $7 in premarket trading Thursday.

Biophytis Secures $1.19M Non-Dilutive Funding For Eye Disorder Program

Biophytis SA BPTS said it was granted a non-dilutive funding of 980,000 euros ($1.19 million) from the public investment bank BPI France's DeepTech program, for its Macuneos in dry age-related macular degeneration.

Macuneos is an orally administered small molecule in development for the treatment of diseases of the retina, or retinopathies. The company said it plans to initiate a Phase 1 clinical trial in healthy volunteers in the second half of 2021.

Can-Fite Says 75% Enrollment Completed In Late-Stage Psoriasis Study

Can-Fite BioPharma Ltd. CANF announced that 75% of patients have been enrolled in its Phase 3 Comfort study designed to establish piclidenoson's superiority compared to placebo and non-inferiority compared to Otezla in patients with moderate to severe plaque psoriasis.

The company said it expects to complete enrollment in the third quarter and report topline results in the fourth quarter.

The stock rose 5.5% to $2.30 in premarket trading Thursday.

Moderna to Invest In Bid To Boost COVID-19 Vaccine Capacity 

Moderna, Inc. MRNA announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities. The company said this will increase global 2022 capacity to up to 3 billion doses of its COVID-19 vaccine, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the company's variant booster candidates and pediatric vaccines, if authorized.

The company plans to use its cash balance to fund these investments.

The company also increased its 2021 supply forecast to between 800 million and 1 billion doses. Additionally, it announced data supporting three-month refrigerated (2-8°C) stable formulation.

Earnings

Hologic, Inc. HOLX said its second-quarter revenues climbed 103.4% year-over-year to $1.538 billion, and non-GAAP EPS came in at $2.59, trailing the consensus estimate of $2.62 per share.

For the third quarter, the company guided to revenues of $1 billion to $1.07 billion and non-GAAP EPS to $1-$1.15. The guidance was also below estimates.

The stock was down 6.77% at $67.50 in after-hours trading.

Alimera Sciences, Inc.'s ALIM first-quarter net revenues fell 23% to $11.2 million and the net loss per share widened from 24 cents to 63 cents. Analysts had expected a smaller loss of 54 cents per share.

The stock moved down 4.95% to $10.75 in after-hours trading.

Viking Therapeutics, Inc. VKTX reported a wider loss of 19 cents per share for the first quarter compared to a loss of 13 cents per share a year ago. Analysts, on average, had estimated a loss of 17 cents per share.

The stock pulled back 4.87% to $6.05 in after-hours trading.

MiMedx Group, Inc. MDXG reported a decline in first-quarter sales and a wider loss.

In after-hours trading, the stock lost 5.32% to $10.14.

On The Radar

PDUFA Dates

The FDA is scheduled to announced its decision on Ardelyx, Inc.'s ARDX NDA for tenapanor in hyperphosphatemia.

Earnings

• Syneos Health, Inc. SYNH (before the market open)
• NovoCure Limited NVCR (before the market open)
• West Pharmaceutical Services, Inc. WST (before the market open)
• Merck & Co., Inc. MRK (before the market open)
• Evelo Biosciences, Inc. EVLO (before the market open)
• Baxter International Inc. BAX) (before the market open)
• Bristol-Myers Squibb Company BMY (before the market open)
• Blueprint Medicines Corporation BPMC (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• Laboratory Corporation of America Holdings LH (before the market open)
• Abiomed, Inc. ABMD (before the market open)
• Amarin Corporation plc AMRN (before the market open)
• Agios Pharmaceuticals, Inc. AGIO (before the market open)
• ResMed Inc. RMD (after the close) (after the close)
• MiMedx Group, Inc. MDXG (after the close)
• BioMarin Pharmaceutical Inc. BMRN (after the close)
• Pacific Biosciences of California, Inc. PACB (after the close)
• Bio-Rad Laboratories, Inc. BIO (after the close)
• Emergent BioSolutions Inc. EBS (after the close)
• ChemoCentryx, Inc. CCXI (after the close)
• DexCom, Inc. DXCM (after the close)
• Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
• Merit Medical Systems, Inc. MMSI (after the close)
• LeMaitre Vascular, Inc. LMAT (after the close)
• MacroGenics, Inc. MGNX (after the close)
• Vertex Pharmaceuticals Incorporated VRTX (after the close)
• Seagen Inc. SGEN (after the close)

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