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Tuesday, May 2, 2023

Hindenburg Unveils Short Position In Icahn Enterprises, Says Company "Inflated By 75%+"

 First it was Gautam Adani, then Jack Dorsey, now it's Uncle Carl Icahn. Shares of Icahn Enterprises are falling in the pre-market session, as research firm Hindenburg Research is taking aim at the legendary corporate raider's holding company in a report that accuses Icahn of "throwing stones" from his own glass house.

The firm says shares of IEP are inflated by more than 75% and, while referring to Icahn as a "legend", says he "has made a classic mistake of taking on too much leverage in the face of sustained losses: a combination that rarely ends well."

Zimmer Biomet raises annual forecasts on knees and hips unit strength

 Zimmer Biomet Holdings Inc raised its annual sales and profit forecasts on Tuesday, banking on strong demand for its knees and hips products amid a sustained recovery in surgical procedures in the United States.

Shares of the Indiana-based medical device maker rose 3.72% to $144 before the bell, also buoyed by better-than-expected first-quarter results.

Zimmer Biomet's upbeat outlook comes after several medical device makers, including Stryker Corp and larger rival Abbott Laboratories, raised their forecasts as easing staffing shortages at hospitals aid a recovery in medical procedures.

Zimmer Biomet, which offers products such as knee replacements and surgical robots, now expects a profit of $7.40 to $7.50 per share for 2023, compared with $6.95 and $7.15 per share previously forecast. Analysts on average were expecting a profit of $7.06 per share, according to Refinitiv data.

The company expects revenue to grow 5%-6% this year, compared with its previous forecast of 1.5%-3.5%.

"Investor focus is largely on Zimmer's ability to take a share in the knee and head market and the adoption of the company's new launches," BTIG analyst Ryan Zimmerman told Reuters before the results.

Analysts have highlighted that Zimmer's smart implant that was authorized by the U.S. health regulator in November for cementless knee replacement procedures will have a broad market opportunity.

The medical device maker's revenue rose 10% to $1.83 billion in the first quarter, beating analysts' average estimates of $1.70 billion.

Excluding items, the company made a profit of $1.89 per share for the quarter ended March 31, compared with analysts' estimates of $1.64 per share.

https://finance.yahoo.com/news/zimmer-biomet-raises-annual-forecasts-122321364.html

Janssen in Pact with Cellular Biomedicine Group to Develop Next Generation CAR-T

 Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. These investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) in China, with the majority of study participants having diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.1,2

DLBCL is characterized by the uncontrolled rapid growth of a type of immune cell called lymphocytes.3 CD20 and CD19 are antigens commonly found on the surface of the cells.4 As many as half of patients with DLBCL eventually become refractory to first-line treatment and require additional treatment options.5 C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed or refractory (R/R) DLBCL. A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with R/R DLBCL is underway. C-CAR066 is an optimized novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with R/R DLBCL is anticipated to begin in the second half of 2023.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Janssen-Enters-Worldwide-Collaboration-and-License-Agreement-with-Cellular-Biome-43711937/

NeuroBo: FDA OKs IND for a Phase 2a NASH Trial

 NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.

https://finance.yahoo.com/news/neurobo-pharmaceuticals-announces-fda-clearance-120100575.html

Immatics: Interim Clinical Data from Ongoing Phase 1b vs. Cancer Target

 Company to host conference call today, May 2, at 8:30 am EDT / 2:30 pm CEST

  • Update covers data from 11 heavily pre-treated, last-line patients in Phase 1b dose expansion Cohort A treated with IMA203 TCR-T monotherapy against PRAME

  • Objective response rate (ORR): 64% (7/11) initial ORR at week 6 and 67% (6/9) confirmed ORR at month 3

  • Median duration of response not reached at median follow-up time of 8.5 months at data cut-off

  • Objective responses independent of solid tumor type at low, medium and high PRAME expression levels in checkpoint-refractory cutaneous melanoma, platinum-resistant ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma

  • Cohort A IMA203 monotherapy TCR-T treatment continues to show manageable tolerability with no high-grade CRS and no ICANS; no dose dependent increase of CRS observed

  • Proprietary rapid manufacturing process with 7 days of manufacturing time; manufacturing success rate of 94% to reach current recommended Phase 2 dose

  • Next data update and pathway towards registration-directed trials planned to be set out in 4Q 2023

  • Company well capitalized with cash position1 of $386m at YE 2022 and reach into 2025 to leverage multi-cancer PRAME opportunity

Immatics conference call
Immatics will host a conference call today, May 2nd, 2023, at 8:30 am EDT / 2:30 pm CEST to discuss the clinical data. The webcast and presentation can be accessed directly through this link. Participants may also access the slides presented in the webcast on the Immatics website in the Investors section under “Presentations” at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on Immatics website for at least 90 days.

Harrow Launches ILEVRO®, NEVANAC®, and MAXIDEX® in the U.S.

 Harrow (NASDAQ: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for ILEVRO® (nepafenac ophthalmic suspension) 0.3%, NEVANAC® (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%. These three FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the five products that Harrow purchased in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/ml, by year-end.

https://finance.yahoo.com/news/harrow-launches-ilevro-nevanac-maxidex-110000094.html

Incyte trades lower as profit falls, tightens Jakafi outlook on strong Q1 sales

 Incyte (NASDAQ:INCY) stock was trading in the red premarket on Tuesday after Q1 results missed estimates, but the company tightened its 2023 net product revenues outlook for bone marrow cancer drug Jakafi.

https://seekingalpha.com/news/3963250-incyte-trades-lower-as-profit-falls-tightens-jakafi-outlook-on-strong-q1-sales