The Daily Biotech Pulse: Hookipa, PDS Biotech Report Positive Data, Ironwood CFO To Depart, Decision Day For Vertex

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 June 7)

Agios Pharmaceuticals, Inc. AGIO
Alkermes plc ALKS
Atossa Therapeutics, Inc. ATOS (scheduled a data presentation for Wednesday)
Eli Lilly and Company LLY
BioCryst Pharmaceuticals, Inc. BCRX
Biogen Inc. BIIB (reacted to FDA approval of its Alzheimer's treatment)
BioNTech SE BNTX
Dicerna Pharmaceuticals, Inc. DRNA
Intra-Cellular Therapies, Inc. ITCI
Maravai LifeSciences Holdings, Inc. MRVI
Misonix, Inc. MSON
Moderna, Inc. MRNA (ongoing momentum got a further lift from regulatory filings in Canada and the EU for authorization of COVID-19 vaccine for adolescents)
Oramed Pharmaceuticals Inc. ORMP
Sesen Bio, Inc. SESN
Talaris Therapeutics, Inc. TALS
Verastem, Inc. VSTM

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 7)

Allogene Therapeutics, Inc. ALLO
Bolt Biotherapeutics, Inc. BOLT
Ionis Pharmaceuticals, Inc. IONS
Longboard Pharmaceuticals, Inc. LBPH

Stocks In Focus

Roche's Antigen Self-Test For COVID-19 Gets CE Mark Approval

Roche Holding AG RHHBY announced it has received the CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests.

"With the CE Mark, the SARS-CoV-2 Antigen Self Test Nasal for rapid self testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways," according to the company.

BeiGene Announces Regulatory Submission For Anti-PD-1 Antibody For Solid Tumors In China

BeiGene, Ltd. BGNE announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental Biologics License Application for the anti-PD-1 antibody tislelizumab for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors.

This submission marks the seventh indication submitted to health authorities, including three approvals for the tislelizumab program, the company said.

Hookipa Announces Positive Phase 1/2 Data For HPV16+ Cancers

HOOKIPA Pharma Inc. HOOK reported positive Phase 1 data from its ongoing Phase 1/2 study of HB-200 for the treatment of advanced human papillomavirus 16-positive cancers.

Data presented as an oral presentation at the 2021 American Society of Clinical Oncology annual meeting showed outstanding T cell responses; preliminary efficacy as a monotherapy in heavily pretreated patients who progressed on standard of care, including checkpoint inhibitors; and favorable tolerability, the company said.

The company also announced translational data suggesting a relationship between T cell response and potential clinical efficacy.

The stock rose 3.4% to $13.70 in after-market trading.

PDS Biotech Presents Positive Phase 2 Data For PDS0101 In HPV16+ Cancer Patients

PDS Biotechnology Corporation PDSB announced presentation at the ASCO meeting, interim data from the Phase 2 trial of PDS0101, in combination with two investigational immune-modulating agents, bintrafusp alfa and NHS-IL12 , showing that 83% of the HPV16-positive cancer patients demonstrated an objective response. All of the patients are still alive.

About 80% of patients who had an objective response still have an ongoing response at eight months.

The stock was up 9.89% at $10.33 in premarket trading Tuesday.

Ironwood Announces Departure of CFO, Names Permanent CEO

Ironwood Pharmaceuticals, Inc. IRWD announced its board named Thomas McCourt, who has served as president and interim chief executive officer since March 12, as permanent chief executive officer. McCourt has also been appointed to serve on Ironwood's Board.

The company also said Gina Consylman plans to step down as SVP and chief financial officer, effective July 2, in order to pursue another leadership opportunity at a rare disease biotechnology company.

The company added that it plans to initiate a search for a permanent successor and intends to name an interim chief financial officer if a permanent successor has not yet been appointed by the date of Consylman's departure.

Inotiv To Join R2K, R3K Indexes

Inotiv, Inc. NOTV, a contract research organization specializing in nonclinical and analytical drug discovery and development services, announced that it is set to join the broad-market Russell 3000 Index and Russell 2000 Index effective after the U.S. markets open on June 28.

Cyclerion Gains On Insider Buying

Cyclerion Therapeutics, Inc. CYCN shares advanced following disclosures of a series of insider buying. CEO Peter Hecht, Terrance McGuire, a director of the board, and Slate Path Capital, all bought shares of the company.

The stock rallied 17.14% to $3.69 in after-hours trading.

Offerings

Histogen Inc. HSTO said it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 5.977 million shares of its common stock, at a purchase price of $1.10 per share, in a registered direct offering priced at-the-market.

Histogen also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 4,782 million shares of its common stock.

The gross proceeds from this offering are expected to be approximately $6.5 million.

The stock slipped 3.7% to $1.04 in after-hours trading.

On The Radar

PDUFA Dates

Vertex Pharmaceuticals Incorporated's VRTX awaits FDA word on the sNDA for Trikafta, its triple combo regimen for cystic fibrosis in children.

The FDA could announce by Tuesday its decision on Pfizer Inc.'s PFE biologic license application for 20-valent pneumococcal conjugate (20vPnC) vaccine.

Clinical Readouts/Presentations

ERA-EDTA Presentations:

Chinook Therapeutics, Inc. KDNY is scheduled to present at the European Renal Association – European Dialysis and Transplant Association Congress with interim data from Part 3 of the phase 1b study of BION-1301 in patients with IgA nephropathy.

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