The Daily Biotech Pulse: MacroGenics' Clinical Trial Disappointment, Sanofi to Buy Kadmon, Alector Loses 2 Key Executives, ADMA's FDA Nod

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 Sept. 7)

• Adial Pharmaceuticals, Inc. ADIL
• Axonics, Inc. AXNX
• Bio-Rad Laboratories, Inc. BIO
• Candel Therapeutics, Inc. CADL (announced completion of patient enrollment in the pivotal phase 3 study of CAN-2409 in prostate cancer)
• Cardiol Therapeutics Inc. CRDL (announced addition to its board)
• Caribou Biosciences, Inc. CRBU
• Catalent, Inc. CTLT
• Celldex Therapeutics, Inc. CLDX
• Cerevel Therapeutics Holdings, Inc. CERE
• Crinetics Pharmaceuticals, Inc. CRNX
• Day One Biopharmaceuticals, Inc. DAWN
• Edwards Lifesciences Corporation EW
• Erasca, Inc. ERAS
• IDEAYA Biosciences, Inc. IDYA
• Imago BioSciences, Inc. IMGO
• INmune Bio, Inc. INMB
• Insulet Corporation PODD
• Intuitive Surgical, Inc. ISRG
• Lyell Immunopharma, Inc. LYEL
• Medpace Holdings, Inc. MEDP
• MiMedx Group, Inc. MDXG
• Monte Rosa Therapeutics, Inc. GLUE
• Nuvalent, Inc. NUVL
• PAVmed Inc. PAVM
• Protagonist Therapeutics, Inc. PTGX (reacted to an executive appointment)
• Psychemedics Corporation PMD
• Quest Diagnostics Incorporated DGX
• ResMed Inc. RMD
• Repligen Corporation RGEN
• ShockWave Medical, Inc. SWAV
• Surrozen, Inc. SRZN ( reacted to positive analyst action)
• Syneos Health, Inc. SYNH
• Tandem Diabetes Care, Inc. TNDM (reacted to the news of inclusion of the stock to the S&P MidCap 400 Index)
• Tango Therapeutics, Inc. TNGX
• Verve Therapeutics, Inc. VERV
• Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

• No NYSE- or Nasdaq-listed stock hit 52-week lows Tuesday.

• Stocks In Focus

MacroGenics' Breast Cancer Combo Drug Flunks a Late-stage Study

MacroGenics, Inc. MGNX announced final overall survival results of the SOPHIA Phase 3 study evaluating Margenza in adult patients with metastatic HER2-positive breast cancer, showing no statistically significant advantage for Margenza, plus chemotherapy, compared to that of patients who received Bristol-Myers Squibb Company BMY's Herceptin plus chemotherapy

In this overall intention-to-treat population, the median survival was 21.6 months in patients treated with Margenza plus chemotherapy, compared to 21.9 months in patients treated with Herceptin plus chemotherapy.

The stock was seen receding 9.92% to $19.61 in premarket trading.

Alector Announces Departure of COO and Chief Medical Officer

Alector, Inc. ALEC announced that Shehnaaz Suliman and Robert Paul will be stepping down from their respective roles as President & chief operating officer and chief medical officer.

Each will continue to serve for a transition period and plan to remain available as advisors until the end of 2021, the company added.
Sam Jackson, SVP, Clinical Sciences, will assume the role of interim chief medical officer.

The stock was slipping 1.24% to $26.39 in premarket trading.

Ascendis Submits Regulatory Application to Commence Phase 1/2 Study of TransCon In Advanced Cancer

Ascendis Pharma A/S ASND announced the submission of an investigational new drug application with the Food and Drug Administration to initiate a phase 1/2 clinical trial to evaluate TransCon IL-2 β/γ in patients with advanced cancer.

TransCon IL-2 β/γ is an investigational long-acting prodrug designed to improve cancer immunotherapy.

Hutchmed, AstraZeneca Commence Phase 3 Lung Cancer Study of Orphathys-Tagrisso Combo In China

HUTCHMED (China) Limited HCM and AstraZeneca PLC AZN have initiated a China Phase 3 study of Orpathys, in combination with AstraZeneca's Tagrisso as a first-line treatment in certain non-small cell lung cancer patients whose tumors harbor EGFR mutation and overexpress MET.

The first patient was dosed on Sept. 7.

Sanofi to Buy Kadmon For $1.8 Billion In Cash

Sanofi announced it has agreed to acquire New York-based biopharma Kadmon Holdings, Inc. KDMN in a $1.9 billion all-cash deal. The deal, according to Sanofi, will support its strategy to continue to grow its General Medicine core assets and will add Kadmon's recently approved Rezurock to Sanofi's transplant portfolio.

In premarket trading, Sanofi shares were down 2% at $50.53, while Kadmon was jumping 75.85% at $9.32.

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

bluebird bio Announces Key Appointments Ahead of Planned Business Separation

bluebird bio, Inc. BLUE announced key management and board appointments in advance of its planned separation, targeted for mid-October, 2021. Amid a few clinical trial setbacks, bluebird bio announced in mid-January plans to separate its oncology business, to be named as 2seventy bio, while retaining focus on severe genetic disease.

The company named Gina Consylman, a finance industry veteran, as the CFO of bluebird bio. Consylman joined bluebird in August 2021 as the CFO of the severe genetic disease business.

Bluebird bio named Marcela, a translational physician-scientist in the field of immunology, to its board. Upon effectiveness of the planned separation, Marcela will join the board of 2seventy bio.

The stock was up 0.63% at $17.48 in premarket trading.

Design Therapeutics Announces Positive Animal Study Data For Rare Inherited Muscular Dystrophy Treatment

Design Therapeutics, Inc. DSGN announced new preclinical data from its novel DM1 GeneTAC program, which demonstrated a near-complete resolution of disease-causing foci and correction of splicing defects in myotonic dystrophy type-1 patient cells.

These data will be presented in a poster titled "Small molecule GeneTACs reduce toxic nuclear foci and correct splicing defects in multiple DM1 cell types," at the 2021 Virtual Myotonic Dystrophy Foundation Annual Conference, being held virtually from Sept. 10-11, the company added.

ADMA Gets FDA Approval for In-house Fill-finish Machine

ADMA Biologics, Inc. ADMA announced that the FDA has granted approval for its in-house aseptic fill-finish machine, the VanRx SA25.

The stock was gaining 18.82% to $1.51 in premarket trading.

Earnings

Offerings

Maravai LifeSciences Holdings, Inc. MRVI announced the commencement of a public offering of its Class A common stock by certain selling stockholders. The selling stockholders are offering 20 million shares of Maravai's Class A common stock. Maravai said it will not receive any proceeds from the sale of shares by the selling stockholders.

The stock was down 5.39% to $56.55 in after-hours trading.

Close on heels of the regulatory nod for its migraine treatment, Impel NeuroPharma, Inc. IMPL announced that it has commenced an underwritten public offering of 3 million shares of its common stock. All of the shares of common stock are being offered by Impel.

In premarket trading, the stock was down 5.76% at $13.74.

On The Radar

Clinical Readouts

Cardiff Oncology, Inc. CRDF will present new data from its Phase 1b/2 clinical trial evaluating onvansertib in combination with standard-of-care FOLFIRI/Bristol-Mysrs Squibb Company BMY's Avastin in KRAS-mutated metastatic colorectal cancer. The presentation is organized as a virtual KOL event for analysts, investors, and the scientific community between 4 pm and 5 pm.

Earnings

Affimed N.V. AFMD (before the market open)