Ayala Sets IPO at 3.33 Million Shares; Sees Pricing at $14-$16

Ayala Pharmaceuticals Inc. on Monday said it expects to sell 3.33 million shares at between $14 and $16 apiece in its planned initial public offering.
At the $15 midpoint of that range, the Wilmington, Del., clinical-stage oncology company said it expects net proceeds of about $44.4 million, or roughly $51.3 million if the underwriters exercise their option to buy an additional 500,000 shares.
Ayala said it will use the proceeds to advance its AL101 and AL102 product candidates, which it is developing for patients suffering from rare and aggressive cancers.
Novartis AG currently holds a 7.2% stake on Ayala, while Bristol-Myers Squibb Co. owns roughly 6.4%, according to a filing with the Securities and Exchange Commission.
Ayala said it will have about 12.6 million shares outstanding after the IPO, assuming exercise of the overallotment option, for a valuation of about $189.2 million at the $15-a-share midpoint.
The company said it has applied to list its shares on the Nasdaq Global Market under the symbol AYLA.

https://www.marketscreener.com/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Ayala-Sets-IPO-at-3-33-Million-Shares-Sees-Pricing-at-14-16-Each-30534694/

BAYER AG: Bernstein gives a Buy rating

In a research note published by Gunther Zechmann, Bernstein advises its customers to buy the stock. The target price is lowered from EUR 86 to EUR 88.
https://www.marketscreener.com/BAYER-AG-436063/news/BAYER-AG-Bernstein-gives-a-Buy-rating-30533098/

GLAXOSMITHKLINE: Goldman Sachs gives a Buy rating

In his latest research note, analyst Keyur Parekh confirms his positive recommendation. The broker Goldman Sachs is keeping its Buy rating. The target price is increased from GBp 1900 to GBp 2060.
https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GLAXOSMITHKLINE-Goldman-Sachs-gives-a-Buy-rating-30533112/

CytoDyn down as CEO sells stock while touting COVID-19 drug

CytoDyn (OTCQB:CYDY -8.8%) is under early pressure on the heels of a report from STAT’s Adam Feuerstein questioning management’s motives behind its aggressive promotion of leronlimab for the treatment of COVID-19 patients.

The company has released a blizzard of press releases (~26 since the first of March) while CEO Nader Pourhassan has appeared on a range of financial news shows touting the potential of the CCR5 inhibitor to treat the respiratory infection. Two studies are underway, one in mild-to-moderately ill patients and one in critically ill patients.

The stock broke out on March 27 after it announced that four COVID-19 patients with respiratory complications treated with leronlimab experienced near-normal immune profiles with improved cytokine levels. Shares have rallied three-fold since then.

A regulatory filing posted on Thursday, April 30, disclosed the potential sale of up to ~46.4M common shares by current investors, including 2.0M shares by Mr. Pourhassan pursuant to warrant exercises. He also apparently plans to sell an additional 2.8M shares, trimming his ownership stake by half.

https://seekingalpha.com/news/3568282-cytodyn-down-9-ceo-sells-stock-while-touting-covidminus-19-drug

Using AI and dyes, new eye test spots glaucoma 18 months early in study

A new, artificial intelligence-powered diagnostic was able to detect the early signs of glaucoma on the cellular level in a clinical trial, a full year-and-a-half before current testing methods.

First developed at University College London with funding from the Wellcome Trust, the test begins with a fluorescent dye injected into the bloodstream. After finding its way to the eye, a genetically modified protein binds the molecular marker to the surface of distressed and dying nerve cells in the retina.

When viewed under standard imaging equipment, the dye lights up the damaged cells. Known as DARC, for detection of apoptosis in retinal cells, the test then uses an automated AI algorithm to scan the image and predict the progression of glaucoma, along with its potential risk for future blindness. In the study, researchers were able to accurately gauge and measure retinal cell damage 18 months before standard OCT eye scans.

“What is really exciting, and actually unusual when looking at biological markers, is that there was a clear DARC count threshold above which all glaucoma eyes went on to progress,” said test developer Francesca Cordeiro, chair of ophthalmology at Imperial College London and professor of glaucoma and retinal neurodegeneration at UCL.

Sensitive biomarkers for slow-moving diseases such as glaucoma are urgently needed and can help speed up the pace of research that would otherwise have to wait years to see changes in symptoms, according to Cordeiro, who also serves as director of the clinical trials unit at Western Eye Hospital London. The results of the phase 2, UCL-sponsored clinical trial were published in the journal Expert Review of Molecular Diagnostics.

“Being able to diagnose glaucoma at an earlier stage, and predict its course of progression, could help people to maintain their sight, as treatment is most successful if provided at an early stage of the disease,” said study first author Eduardo Normando, a senior lecturer at Imperial College London. “After further research in longitudinal studies, we hope that our test could have widespread clinical applications for glaucoma and other conditions.”

The test is being developed by the London-based startup Novai, which counts Cordeiro as chief scientific officer, for both glaucoma and age-related macular degeneration—and is exploring its use in other degenerative conditions stemming from the loss of cells, such as multiple sclerosis and dementia.

In addition, shortly after launching last month, the company announced a collaboration with the U.S. division of the Japanese ophthalmology biotech Santen.

https://www.fiercebiotech.com/medtech/using-ai-and-dyes-a-new-eye-test-spots-glaucoma-18-months-early-a-clinical-study

Immunomedics’ Trodelvy now available in U.S.

Immunomedics (IMMU -0.3%) announces that Trodelvy (sacituzumab govitecan-hziy) is now available through major specialty distributors in the U.S. and that the first patient was treated on April 29, 2020.

Trodelvy is the first anti-Trop-2 ADC recently approved by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

https://seekingalpha.com/news/3568278-immunomedics-trodelvy-now-available-in-u-s

Moonlighting MDs in Best Position to Help During COVID

COVID-19 has turned both the entire country and the world of healthcare on its head. Nobody could have predicted what’s happened over the last couple of weeks, and preparations and concerns about the upcoming onslaught of patients, have shaken the medical community to its core. Where exactly on the curve are we? Do we have enough hospital capacity? How do we get adequate personal protective equipment for our frontline healthcare workers? Individual states are responding to the crisis by making it easier for physicians to reach these frontlines. Senior medical students are being fast-tracked through to graduation, and practicing doctors are seeing all the usual licensing and credentialing bureaucracy, being slashed. In short, if you practice medicine — you are needed fast.
Any physician who regularly works at more than one institution will already be used to working in different environments, interacting with hundreds of staff members, and well-versed in using different electronic medical records. They are less likely to feel overwhelmed going into a new hospital or clinic than, for example, a doctor who has only worked in one place for the last decade. These clinicians are therefore in an ideal position to step up at this time of need.
When you hear about institutions in need of help, assess any obvious practicalities such as distance from home, and get a full picture of what you will be getting yourself into — including the acuity of the current situation and any potential equipment shortages. You will still need to do all of the usual negotiating over your pay and review your contract thoroughly (but typically during an emergent situation, the spirit is one of flexibility on both sides). If you decide to proceed, you will likely be fast-tracked through medical credentials so that you are ready to start working ASAP. Assuming you have no major concerns on your record, this should be a breeze.
Away from a hospital or clinic, there are also other ways you can utilize your medical skills in these extraordinary times. Telemedicine is a surging field, which will likely be new to most doctors. In the current climate, it’s obviously so much safer for patients to communicate with doctors from home, either for new non-emergent problems (including minor symptoms that they are worried could be COVID-19) or for ongoing follow-up. From a federal (Medicare) level, prior restrictions on the use of telemedicine have been lifted. Many states, such as Massachusetts, have taken additional bold steps to dramatically expand telemedicine access (Massachusetts has mandated that all commercial insurance payers reimburse for these services).
Just over the last couple of weeks, seniors have been using FaceTime and other apps for the first time, to talk with their doctors from the comfort of their own home! They don’t have to immerse themselves in the healthcare setting and face the additional risk of exposure. As for the doctors, they can either be in their clinic or home office. If you are willing to give telemedicine a try, this could be just the right time to start on what will undoubtedly be the wave of the future.

However you decide to help in this national crisis — hospital, clinic, or telemedicine: Your country and patients need you.
Suneel Dhand, MD, is an internal medicine physician, author, and speaker. He is the co-founder of DocsDox, a service that helps physicians find local moonlighting and per diem opportunities, bypassing the expensive middleman.
https://www.medpagetoday.com/infectiousdisease/covid19/86274