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)

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

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. (NASDAQ: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 (NASDAQ: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

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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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.

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

On The Radar

Clinical Readouts

Earnings

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