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News from NFLS & Pivotal Life Sciences

Arcutis Announces Positive Topline Results from ARRECTOR Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Scalp and Body Psoriasis

Study met both co-primary endpoints and all secondary endpoints. At week eight, 67.3% of individuals treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success compared to 28.1% of individuals treated with vehicle
At week eight, 46.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.8% of individuals treated with vehicle
Once-daily roflumilast foam demonstrated a favorable safety and tolerability profile

Rallybio Announces Positive Preliminary Results for RLYB212, an anti-HPA-1a Monoclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia

NEW HAVEN, Conn.–(BUSINESS WIRE)–Rallybio Corporation (Nasdaq: RLYB) today announced positive preliminary results from its ongoing Phase 1b proof-of-concept study of RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). These data demonstrate that one week after a single subcutaneous dose, RLYB212 was able to eliminate transfused HPA-1a positive platelets rapidly compared to placebo in a challenge model of a catastrophic fetal maternal hemorrhage. Additional pharmacokinetic data suggests the opportunity for less frequent dosing.

Evommune Initiates Phase 2a Proof-of-Concept Clinical Trial to Evaluate EVO101 in Atopic Dermatitis

Palo Alto, Calif., Sept. 28, 2022 – Evommune, Inc., a clinical-stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced enrollment of the first patient in a Phase 2a proof-of-concept clinical trial evaluating EVO101, a novel small molecule inhibitor of interleukin 1 receptor-associated kinase 4 (IRAK4), in patients with atopic dermatitis (AD). The Phase 2a trial is a randomized, double-blind, parallel group, vehicle-controlled study which will assess the safety, tolerability and preliminary efficacy of EVO101 topical cream, 0.1% BID, in 118 adults with mild to moderate AD in clinical sites
across the United States.

Plexium Strengthens Leadership Team With Appointment of Daniel Sipes As Senior Vice President, Head of Technology

Plexium, Inc. (Plexium), a leading next-generation targeted protein degradation (TPD) company, today announced the appointment of Daniel Sipes as Senior Vice President, Head of Technology. Mr. Sipes brings over two decades of experience in developing and implementing new technologies for drug discovery to Plexium, with a focus on next-generation high throughput screening and novel assay development.

Top-Notch Karuna Therapeutics Breaks Out To Record High On Schizophrenia Win

Karuna Therapeutics (KRTX) topped expectations Monday in a study of its schizophrenia treatment, and the biotech stock soared to a record high.On the stock market today, biotech stock Karuna catapulted 71.8% to 241.19. The company tested its drug in patients with schizophrenia for five weeks. At the end of the test, patients who received the drug showed a 9.6-point reduction on a scale of symptoms compared to the placebo recipients. The scale measures 30 items related to psychopathic behavior.

FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older

First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis
Approved for once-daily treatment in mild, moderate, and severe plaque psoriasis with no limitations on duration of use
Established efficacy – provides rapid clearance of plaques and reduction of itch in all affected areas of the body
Safe and very well-tolerated, steroid-free cream with minimal application site reactions
Commercial product expected to be available by mid-August
Management will host conference call on Monday, August 1 at 8:30 a.m. EDT

HotSpot gets hotter with $100M raise to push toward clinic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

The cash won’t stop for Exscientia as it makes a $300M+ Nasdaq debut

Thursday, too, saw Exscientia raise more than just the IPO. In conjunction with the pricing, the Oxford, UK-based biotech got another $160 million in private placements from SoftBank and the Bill and Melinda Gates Foundation. With the debut, details about the big IPO winners are coming into focus. The biggest shareholder is now SoftBank, which will get a 16.3% stake after the offering. CEO Andrew Hopkins is second on the list with 15.8% of shares.

Obsidian Therapeutics Announces Closing of $115 Million Series B Financing

Funding to Advance Pipeline of Engineered TIL Therapies for Solid Tumors into Clinical Studies
Existing investors Atlas Venture, Vertex Ventures HC, Amgen Ventures, and Bristol Myers Squibb participated in the financing.Also participating in the round is Vertex Pharmaceuticals, with whom Obsidian recently executed a collaboration to discover novel therapies that regulate gene editing.

Vigil raises $90M in neuroscience ‘renaissance.’ Is an IPO around the corner?

A couple of years ago, Amgen joined Big Pharma’s mass exodus from neuroscience, as execs either abandoned or trimmed back their programs in the field.

Now, a small Cambridge, MA-based biotech is sprinting toward the clinic with two of Amgen’s old TREM2 assets, and investors are putting down $90 million ahead of what they believe could be neuroscience’s big comeback.

Eargo Sets a New Bar In Hearing Aid Technology

While hearing health issues have historically been under-emphasized, it’s estimated that 360 million people suffer from some form of hearing loss (over 5% of the global population) worldwide…

Eargo Max Hearing Aid Unboxing Review

Eargo Max delivers advanced sound quality for more gain and volume +(5dB). And with our patent-pending Flexi Domes, you get even greater volume and fuller sound…

Top 10 Gadgets From CES

CES 2018 was, as usual, filled with futuristic and fascinating new technologies and devices. But much of this new gear is likely never make it to market, or is more provocative than practical…

The Verge Awards at CES 2018: Hey Google

The CES crowd seems to be dwindling every year as more tech companies wait until events like Mobile World Congress or their own developer shows to announce new products…

Eargo Reinvents the Hearing Aid, Again!

Mountain View, Calif. – Jan. 09, 2018 /PRNewswire/– Eargo, the award-winning, direct-to-consumer hearing technology company, today announced the launch of Eargo Max, their best hearing aid yet.

Eargo Raises Up To $45 Million in Series C Funding

Mountain View, Calif. – Oct. 19, 2017 – Eargo (www.eargo.com), the innovative, direct-to-consumer hearing technology company renowned for the world’s smallest, most comfortable, and rechargeable hearing aid…

CEO Update: Living our Dream. Every Day.

It wasn’t too long ago that we kicked off our mission in earnest to provide a new solution to help empower those with hearing loss. We’re here to make hearing easy; there’s never been more of a need…

A Great Night at the Clio Awards

Just like our customers, most of us who work at Eargo are unique in almost every way imaginable. Some of us are night owls, some of us early risers. Some of us listen to the Beatles, others went to their concerts…

This Funky Looking Hearing Aid Isthe Future

I have hearing problems. It’s been a fact of life for as long as I can remember. A couple years ago, a surgeon and a tiny piece of titanium corrected the worst of those problems, but I’m due for another procedure.