The Daily Biotech Pulse: Hologic Goes Shopping, Johnson & Johnson Snaps Ties With Geron

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 on Sept. 26)

  • Abbott Laboratories ABT
  • Aldeyra Therapeutics Inc ALDX(released positive Phase 2b results for its dry eye disease treatment candidate reproxalap)
  • Becton Dickinson and Co BDX
  • Boston Scientific Corporation BSX
  • CareDx Inc CDNA
  • Edwards Lifesciences Corp EW
  • Mesoblast limited MESO
  • OASMIA PHARMACE/ADR OASM
  • ResMed Inc. RMD
  • Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 26)

  • Aerpio Pharmaceuticals Inc ARPO
  • Avadel Pharmaceuticals PLC AVDL
  • Aytu Bioscience Inc AYTU
  • Biocept Inc BIOC
  • CELLECT BIOTECH/S ADR APOP
  • Eidos Therapeutics Inc EIDX
  • Erytech Pharma SA ERYP
  • GTx, Inc. GTXI
  • Iterum Therapeutics PLC ITRM
  • Kala Pharmaceuticals Inc KALA

Stocks In Focus

Eli Lilly In-Licenses Pre-Clinical Diabetes Asset

Eli Lilly And Co LLY and Japan's Chugai announced a licensing agreement, which provides for the former licensing the latter's oral non-peptide GLP-1 receptor agonist OWL833, which is a Phase-1 ready asset being studied for treating type 2 diabetes.

The financial terms include Eli Lilly paying Chugai $50 million in upfront payment and potential milestone payments. If commercialized, Chugai is also eligible to receive royalty payments. In return, Lilly gets the worldwide development and commercialization rights to OWL83.

Hologic To Acquire Focal Therapeutics

Hologic, Inc. HOLX announced an agreement to buy privately-held Focal Therapeutics, which has developed a marker that improves the standard of care for breast cancer patients by creating a permanent, three-dimensional indicator of the surgical site. Hologic agreed to pay $125 million in cash for the proposed buy.

See Also: Viking Shares Jump After Fatty Liver Drug Meets Midstage Trial Endpoints

Histogenics Sets Up Tryst With FDA For its Orthopedic Restorative Cell Therapy

Histogenics Corp HSGX said the FDA has granted a Type C meeting Oct. 30 to discuss topline results from the Phase 3 clinical trial for NeoCart and the company's planned BLA submission.

"NeoCart, is designed to rebuild a patient's own knee cartilage to treat pain at the source and potentially prevent a patient's progression to osteoarthritis," the company said.

Geron, J&J Unit Janssen Discontinue Imetelstat Collaboration

Geron Corporation GERN said Johnson & Johnson JNJ's Janssen unit has terminated the 2014 Collaboration and License Agreement with regard to the former's Imetelstat, a first-in-class telomerase inhibitor, effective Sep. 28. Geron now has regained the global rights to develop and commercialize the asset.

Imetelstat is being evaluated for treating myelofibrosis.

"We also believe the combined data of 38 patients from the initial and expansion cohorts for the target patient population from the Phase 2 portion of IMerge support further development of imetelstat, and we are therefore prioritizing the initiation of the Phase 3 portion of IMerge," the company said.

Aldeyra To Offer Shares

Aldeyra Therapeutics Inc ALDX said it intends to offer and sell 5.25 million shares in an underwritten public offering. All the shares are to be offered by the company. The company said it intends to use net proceeds for the continued development of its lead compound reproxalap and its other product candidates as well as for debt maintenance, working capital and other general corporate purposes.

On The Radar

PDUFA Date

The FDA is set to rule on Adamis Pharmaceuticals Corp ADMP's sNDA low dose Symjepi (epinephrine) injection for treating Anaphylaxis. Symjepi 0.3 mg dosage is already approved for treating Type 1 allergic reactions, including anaphylaxis, designed for patients weighing 66 pounds or greater. The low dose version, the review of which is pending before the FDA, is 0.15 mg in strength and is intended to potentially treat patients weighing 33-65 pounds.

IPO

Urovant Sciences priced its 10 million-share IPO at $14 per share, the lower end of the estimated price range of $14 to $16. The shares would be listed on the Nasdaq under the ticker symbol UROV. The company develops an acquired oral therapy for overreactive bladder.

Sutro Biopharma, a biotech company developing immuno-oncology, priced its upsized offering of 5.67 million shares at $15, the mid-point of the estimated price range of $14-$16. The shares will listed on the Nasdaq under the ticker symbol STRO.

Ra Medical Systems, which commercializes excimer lasers used to treat dermatologic and vascular diseases, priced its upsized offering of 3.90 million shares at $17, higher than the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol RMED.

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