The Daily Biotech Pulse: Decision Day For Amgen, Zymeworks Sinks On Data, Ortho Clinical Diagnostics IPO - iShares Biotechnology ETF (NASDAQ:IBB)

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 Jan. 27)

Abbott Laboratories ABT (reacted to fourth-quarter results)
Aslan Pharmaceuticals Ltd ASLN
Atea Pharmaceuticals Inc AVIR
AtriCure Inc. ATRC
Aziyo Biologics Inc AZYO
Cassava Sciences Inc SAVA
Collegium Pharmaceutical Inc COLL
Collplant Biotechnologies Ltd – ADR CLGN
Corcept Therapeutics Incorporated CORT
Frequency Therapeutics Inc FREQ (reacted to ratings upgrade by JPMorgan to Overweight)
Fulgent Genetics Inc FLGT
GW Pharmaceuticals PLC- ADR GWPH
Illumina, Inc. ILMN
ImmuCell Corporation ICCC
Integra Lifesciences Holdings Corp IART
Kaleido Biosciences Inc KLDO
LeMaitre Vascular Inc LMAT
Ligand Pharmaceuticals Inc. LGND
Merit Medical Systems, Inc. MMSI
Nantkwest Inc NK
Penumbra Inc PEN
Regulus Therapeutics Inc RGLS
Rubius Therapeutics Inc RUBY
Silence Therapeutics ADR Representing 3 Ord Shs SLN
Summit Therapeutics Inc SMMT
Supernus Pharmaceuticals Inc SUPN
Tenax Therapeutics Inc TENX
Vanda Pharmaceuticals Inc. VNDA
Viking Therapeutics Inc VKTX
Vincerx Pharma Inc VINC
Vir Biotechnology Inc VIR - announced a collaborative study with Eli Lilly And Co LLY for testing combination of two COVID-19 antibody therapies in low-risk patients with mild-to-moderate COVID-19

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 27)

Akouos Inc AKUS
Fusion Pharmaceuticals Inc FUSN
Gracell Biotechnologies Inc GRCL

Stocks In Focus

Applied Genetic Reports Positive Results For Gene Therapy Study To Treat Absence Of Color Vision

Gene therapy company Applied Genetic Technologies Corp AGTC said preliminary results from the Phase 1/2 study of its AAV-based gene therapy in achromatopsia suggested sustained improvements to 12-months in visual sensitivity, as measured by full field static perimetry, supported in some patients by other endpoints.

Separately, the company said it is offering to sell shares of its common stock and pre-funded warrants, together with accompanying warrants to purchase shares of its common stock in an underwritten public offering. All of the securities in the proposed offering are being sold by the company.

The stock was up 1.12% at $4.50 premarket Thursday.

Zymeworks' Phase 1 Data For Tumor Drug Fails to Cut Ice With Investors

Issuing an update on the Phase 1 study of its HER2 bispecific antibody-drug conjugate ZW49, Zymeworks Inc ZYME said it demonstrated antitumor activity across all regimens and dose levels evaluated to date, including at the starting dose of 1 mg/kg once every two weeks.

In the 35 patients who have received ZW49 across all dosing regimens, there have been no toxicities or treatment-related deaths.

"ZW49 had two confirmed partial responses out of six efficacy evaluable patients (33% overall response rate, tumor types not specified) at the highest doses evaluated, which we think fails to meet investors' expectations into the event for an overall response rate of 40%-50% across multiple tumors," SVB Leerink analyst Andrew Berens said in a note.

The stock was down 18.07% premarket at $36.10.

OraSure's Saliva Collection Device Approved For Use In COVID-19 Testing in Canada

OraSure Technologies, Inc. OSUR announced its OMNIgene ORAL saliva collection device, a product of Ottawa-based subsidiary DNA Genotek, has received authorization from Health Canada for use as a component in molecular diagnostic tests for the detection of SARS-CoV-2.

The stock was down 0.58% to $13.81 in premarket trading Thursday.

Teligent Announces Strategic Actions to Enhance Financial Flexibility

Teligent Inc (NEW JERSEY) TLGT announced a series of strategic actions in partnership with its senior lenders and its Series C noteholders to recapitalize and enhance its financial flexibility.

Accordingly, the company's Series C noteholders, primarily Silverback Asset Management, Nantahala Capital Management and its senior secured lenders, have converted approximately $77 million of total debt into equity. Additionally, a second lien credit agreement has been amended to provide $4.6 million in incremental financing through delayed draw term loans.

The company has also entered into an at-the-market issuance sales agreement with B. Riley Securities, Inc. pursuant to which the company may, from time to time, in its discretion, offer and sell shares of its common stock with a total value of approximately $22.62 million.

The stock was soaring 12.22% to $1.01 premarket Thursday.

Celcuity To Collaborate With Pfizer For Breast Cancer Trial

Celcuity Inc CELC announced a clinical trial collaboration with the Sarah Cannon Research Institute and Pfizer Inc. PFE to conduct a Phase 2 clinical trial to evaluate the efficacy and safety of two Pfizer's targeted therapies, Vizimpro and Xalkori.

Under the agreement, Pfizer will supply its FDA-approved lung cancer therapies, Vizimpro and Xalkori, while Celcuity will provide its CELsignia Multi-Pathway Activity Test to select patients with HER2-negative metastatic breast cancer who have hyperactive HER2 and c-Met signaling pathways for the trial and will fund the patient-related trial costs.

Celcuity shares were up 3.95% premarket to $13.30.

Liminal To Explore Strategic Options For Plasma-Derived Therapeutics Business

Liminal BioSciences Inc LMNL said it has decided to re-focus its resources on its small molecule therapeutics business and has commenced a process to evaluate potential strategic alternatives for its plasma-derived therapeutics business, aimed at minimizing cash burn.

These alternatives may result in a divestment, in whole or in part, of the plasma-derived therapeutics business and/or other non-core assets, or in other courses of action including but not limited to other strategic transactions or the closure of its Ryplazim related operations, the company said.

The stock was down 2.17% premarket at 96 cents.

Earnings

Edwards Lifesciences Corp's EW fourth-quarter sales rose 1% to $1.2 billion, and adjusted EPS rose 2% to 50 cents, trailing the 53-cent-per-share consensus estimate. The company's first quarter guidance was lackluster, while the full-year guidance was in line.

In after-hours trading, the stock slid 2.17% to $83.

Hologic, Inc. HOLX reported an 89.3% year-over-year increase in revenue for the first quarter of fiscal year 2021 to $1.61 billion. Non-GAAP EPS came in at $2.86. The results exceeded estimates. The company issued upbeat guidance.

The stock was up 3.02% to $74.70 in after-hours trading.

On The Radar

PDUFA Dates:

The FDA is scheduled to rule on Amgen, Inc.'sAMGN sBLA for Nplate, a peptibody protein that works by raising and sustaining platelet counts, as a treatment option for Hematopoietic Syndrome of Acute Radiation Syndrome.

Clinical Readouts:

Earnings:

ABIOMED, Inc. ABMD (before the market open)
ResMed Inc. RMD (after the close)

IPOs

Raritan, New Jersey-based Ortho Clinical Diagnostics Holdings plc priced its initial public offering of 76 million ordinary shares at $17 per share for raising gross proceeds of $1.292 billion. Th company had expected to price the offering between $20 and $23. Ortho's ordinary shares will begin trading on Nasdaq under the symbol "OCDX."

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